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Date: Wednesday, May 1
Time: 11:45am - 12:30pm
Track: Drug Manufacturing
Vault Recording: TBD
Registrar Corp’s Melissa Sayers will present on new U.S. FDA electronic common technical document (“eCTD”) requirements for Drug Master Files (DMFs). Attendees will learn the benefits of utilizing DMFs for their products as well as the regulatory requirements for employing DMFs.
Innovative ideas need protection from competitors. Drug companies submit DMFs to FDA to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information within the DMF submission in support of NDA, ANDA, and other FDA submissions without disclosing the information to anyone other than FDA.
Once companies with innovative new ingredients, coatings, packaging, etc. are able to navigate the regulatory requirements of DMFs, they can utilize a DMF to incorporate their innovative products in others’ drug products without subjecting their innovation to imitation.